510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 364 of 1190
FDA device recalls, page 364 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0834-2020Class IIHenry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036Polymer Technology SystemsNBW
Z-0779-2020Class IIMedical convenience trays and kits, labeled as: Medical Action Industries...Medical Action Industries, Inc. 306KDD
Z-0746-2020Class IIHeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI...Abbott MedicalDSQ
Z-0773-2020Class IIInvia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam...Medela AGOMP
Z-0833-2020Class IIPTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box...Polymer Technology SystemsNBW
Z-0832-2020Class IIPTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying...Polymer Technology SystemsNBW
Z-1675-2020Class IIaap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00AAP Implantate AGGAD
Z-0800-2020Class IIQuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI...Edwards Lifesciences LLCDWF
Z-0804-2020Class IIBriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use...Flexicare Medical Ltd.OGH
Z-0803-2020Class IIBriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx...Flexicare Medical Ltd.OGH
Z-0802-2020Class IIBriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF...Flexicare Medical Ltd.CCW
Z-0801-2020Class IIBriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF...Flexicare Medical Ltd.CCW
Z-0762-2020Class IIiMRX MRI and Angiography System, part number 10094137 and 10094141, a...IMRIS Imaging, Inc.LNH
Z-0818-2020Class IIVACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE...Greiner Bio-One North America, Inc.JKA
Z-0814-2020Class ICarestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide...GE HealthcareBSZ
Z-0813-2020Class ICarestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide...GE HealthcareBSZ
Z-0782-2020Class IICios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging...Siemens Medical Solutions USA, Inc.OWB
Z-1439-2020Class IIbellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically...Jaeger Medical GmbHCBK
Z-1225-2020Class IITerumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019...Terumo Cardiovascular Systems CorporationKRD
Z-1224-2020Class IITerumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026...Terumo Cardiovascular Systems CorporationKRD
Z-1223-2020Class IITerumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System...Terumo Cardiovascular Systems CorporationKRD
Z-1222-2020Class IITerumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032...Terumo Cardiovascular Systems CorporationKRD
Z-1221-2020Class IITerumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026...Terumo Cardiovascular Systems CorporationKRD
Z-1220-2020Class IITerumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System...Terumo Cardiovascular Systems CorporationKRD
Z-2425-2020Class IILOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .Zest Anchors LLCDZE
Z-1407-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1406-2020Class IIMicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC...Terumo Cardiovascular Systems CorporationHCG
Z-1405-2020Class IIMicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization...Terumo Cardiovascular Systems CorporationHCG
Z-1404-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1403-2020Class IIMicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization...Terumo Cardiovascular Systems CorporationHCG
Z-1402-2020Class IIMicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization...Terumo Cardiovascular Systems CorporationHCG
Z-1401-2020Class IIMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1400-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1399-2020Class IIMicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF...Terumo Cardiovascular Systems CorporationHCG
Z-1398-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1397-2020Class IIMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1396-2020Class IIMicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1395-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1394-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1393-2020Class IIMicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil...Terumo Cardiovascular Systems CorporationHCG
Z-1392-2020Class IIMicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization...Terumo Cardiovascular Systems CorporationHCG
Z-0670-2020Class IIMonaco Radiation Treatment Planning System (RTP) SystemElekta LimitedMUJ
Z-2139-2020Class IIABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941...Radiometer Medical ApSCHL
Z-2138-2020Class IIABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526...Radiometer Medical ApSCHL
Z-0805-2020Class IICAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort...Caire, Inc.CAW
Z-0681-2020Class IIThe products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S...Stanley Black & Decker Inc.RER
Z-0781-2020Class IIStryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod...Stryker Corp.JEC
Z-0958-2020Class IMedtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711...Medtronic, Inc.OZP
Z-0957-2020Class IMedtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and...Medtronic, Inc.OZP
Z-0956-2020Class IMedtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741...Medtronic, Inc.OZP